AcuVid COVID-19 Rapid Antigen Saliva Test
Manufactured by Therma Bright Inc., Canada - https://www.thermabright.com/
Device identification number
2110
CE Marking
✓Yes
HSC common list (RAT)
×No
Physical Support
Cassette
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
ACUViD COVID-19 Saliva Antigen Test is a lateral flow immunoassay to detect SARS-CoV-2 nucleocapsid antigens in human saliva specimens from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests. The test is intended for use by healthcare providers or personnel trained in rapid test procedure, as an aid in identifying SARS-CoV-2 infection.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Sample collection device
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Enzyme-linked
LOD
-1 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
False positive results may arise from: o Cross-contamination during specimen handling o Cross-cont
False negatives
False negative results may arise from: o Improper specimen collection or handling o Use of unautho
Precision
Evaluated
Accuracy
96.6 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.6 %
Clinical Specificity
90 %
Type of antigen
Nucleoprotein
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements